21 CFR 876.5220
Colonic irrigation system
21 CFR 876.5220 is the regulation titled “Colonic irrigation system” in 21 CFR Part 876, Gastroenterology-Urology Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
The regulation
Read the text of 21 CFR 876.5220 (eCFR, as of Sep 1, 2026)
(a) Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).
(b) Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 876.5220.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.40Document controls1 letter cites both
- 21 CFR 820.70Production and process controls1 letter cites both
- 21 CFR 830.3Definitions1 letter cites both
- 21 CFR 830.300Devices subject to device identification data submission requirements1 letter cites both
Latest letters citing it
The letter citing 21 CFR 876.5220 that FDA posted most recently.
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